疫苗生产污染控制策略及检查要点分析  

Contamination Control Strategy and Inspection Points of Vaccine Manufacturing

作　　者：崔翔 王金伟 Cui Xiang;Wang Jinwei(Center for Inspection of Jiangsu Medical Products Administration,Nanjing 210019,China)

机构地区：[1]江苏省药品监督管理局审核查验中心,江苏南京210019

出　　处：《广东化工》2024年第6期78-79,77,共3页Guangdong Chemical Industry

摘　　要：药品为预防、控制和治疗疾病提供了强大的保障,在全球公共卫生体系中扮演着至关重要的角色,疫苗作为特殊的药品,其生产工艺更为复杂,是近年来药品监管部门关注的重点。自新版欧盟GMP附录一提出污染控制策略(CCS)以来,CCS已受到药品生产企业和药品检查人员的广泛关注。本研究以疫苗生产工艺过程为主线,结合近几年疫苗检查发现的CCS相关缺陷,分别从人员污染控制、设备与组件污染控制、物料污染控制、设施与环境污染控制、清洁验证等方面分析疫苗污染控制的关注要点。Pharmaceuticals provide a strong guarantee for the prevention,control and treatment of diseases,and play a key role in the global public health system.The latest EU GMP Annex 1 Manufacture of Sterile Medicinal Products proposes a concept of contamination control strategy(CCS),it has received widespread attention from medical manufacturers and inspectors.Based on the vaccine manufacturing process and the CCS-related inspection defects in recent years,this study analyzes the key points of vaccine Contamination control strategy from the aspects of personnel,equipment,component,material,facility,environmental and cleaning validation.

关 键 词：无菌药品 疫苗 污染控制策略 有效性 检查 

分 类 号：R9[医药卫生—药学]